Postoperative Adjuvant Immunotherapy Combined with Radiotherapy Versus Surgery Alone in Locally Advanced UTUC

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Sep 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced ureter cancer or renal pelvic carcinoma. Specifically, researchers want to see if adding immunotherapy (which helps the body's immune system fight cancer) to postoperative radiotherapy (a treatment using high-energy rays to kill cancer cells) is more effective than surgery alone for patients who have had their kidneys and ureters removed and have more advanced cancer stages. The trial is currently recruiting participants aged 18 to 80 who have undergone this surgery and meet certain health criteria.

To be eligible for this trial, patients must have been diagnosed with specific advanced stages of ureter cancer or renal pelvic cancer and should not have distant cancer spread at the time of surgery. They should also be in reasonably good health, with certain blood counts and kidney function levels. Participants can expect to undergo follow-up visits and tests to monitor their health throughout the study. This trial could provide valuable information on how to improve treatment options for patients facing this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1) Patients after radical nephroureterectomy with full-length nephroureterectomy and pathologically confirmed cancer of the renal pelvis or ureter, AJCC staging (8th edition) containing one of the following factors: pT3-4, pN+; 2) Patients with creatinine eGFR \<60 min/L. or underlying disease refusing to tolerate chemotherapy.
• • 3)18≤age≤80 years old; 4)Completion of abdominopelvic CT 4 weeks prior to enrolment. 5)Except for cutaneous non-melanoma and ductal carcinoma in situ of the breast, the patient has not suffered from any other malignant disease within the last 5 years; 6)Willing to participate in perfecting the necessary examinations and follow-up visits for the sake of the study, and willing to provide written informed consent.
• All of the above need to be fulfilled:
• • Expected survival \> 6 months; KPS \> 70 points; Leukocytes ≥ 3.5 x 109/l,Neutrophils ≥ 1.5 x 109/l, Platelets ≥ 100.0 x 109/l, Haemoglobin ≥ 90g/l.
• Exclusion Criteria:
• • 1) Distant metastases already found at the time of surgery; non-R0 resected patients 2) History of pelvic and abdominal radiotherapy; history of inflammatory bowel disease; history of systemic chemotherapy; (3) Pregnant or breastfeeding women; or women of childbearing potential who are not using reliable contraception; (4) History of malignant tumour (except skin cancer that is not malignant melanoma and cervical cancer in situ, tumours that have been cured for more than 5 years) 5) weight loss \> 10% within 6 months 6) Presence of active infections in those with pre-existing or co-existing bleeding disorders 7) clinically significant cardiac disease (e.g., hypertension controlled by medication, unstable angina pectoris, New York Heart Association (NYHA) class ≥ II congestive heart failure, unstable symptomatic arrhythmia, or class ≥ II peripheral vascular disease); 8) Psychological, family, and social factors leading to lack of informed consent.